Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07423078 | Window of Opportunity in Preserving Laryngeal Function Trial | PHASE2 | RECRUITING | 87 | — | — | Apr 6, 2026 | Apr 30, 2031 | Apr 13, 2026 | 1 | United States |
Proportion of patients who have not experienced disease recurrence/progression or death from any cause at 1 year from start of treatment. Radiologic (CT or MRI) imaging as well as direct visualization by laryngoscopy will be used to assess disease with recurrence requiring a biopsy to be considered positive.
| Arm | Type | Description |
|---|---|---|
| toripalimab + carboplatin + paclitaxel | EXPERIMENTAL | Prior to treatment: Assessments include laryngoscopy and anatomic imaging studies Treatment: toripalimab 240mg IV with carboplatin (AUC 5) and paclitaxel (175 mg/m\^2) IV every 3 weeks for two cycles. (Cisplatin 75mg/m\^2 can be used in place of carboplatin at the investigator's discretion.) After 2 Cycles of Treatment: Repeat laryngoscopy and anatomic imaging studies. Undergo swallowing function and extranodal extension status assessment. |
| Post-bioselection: Chemoradiation + toripalimab monotherapy | EXPERIMENTAL | Patients with PR ≥50% (not CR) with preserved swallowing function or CR, with preoperative N+ disease and extranodal extension upon neck dissection. Induction Treatment: toripalimab 240mg IV+carboplatin (AUC 5)+paclitaxel (175 mg/m\^2) IV Q Continuation Treatment: toripalimab 240mg IV + carboplatin (AUC 5) + paclitaxel (175 mg/m\^2) IV Q + Radiation therapy as per the Intervention Description + toripalimab 240mg IV monotherapy for 8 cycles |
| Post-bioselection: Radiation + toripalimab monotherapy | EXPERIMENTAL | Patients with CR, with preoperative N0 disease or N+ disease with no extranodal extension upon neck dissection. Induction Treatment: toripalimab 240mg IV+carboplatin (AUC 5)+paclitaxel (175 mg/m\^2) IV Q Continuation Treatment: Radiation therapy as per the Intervention Description + toripalimab 240mg IV monotherapy for 8 cycles |
| Name | Type | Description |
|---|---|---|
| Toripalimab | DRUG | A monoclonal antibody (recombinant humanized programmed cell death protein 1 (PD-1) monoclonal antibody that acts as a checkpoint inhibitor) used for the treatment of melanoma and nasopharyngeal carcinoma. |
| Carboplatin | DRUG | A chemotherapy medication classified as an alkylating agent. It contains the metal platinum, which binds to DNA in cancer cells, preventing their replication and leading to cell death. This mechanism makes it effective against rapidly dividing cells, such as cancer cells. |
| Cisplatin | DRUG | \*Can be used in place of carboplatin at the investigator's discretion. A chemotherapy medication classified as an alkylating agent. It contains the metal platinum, which binds to DNA in cancer cells, preventing their replication and leading to cell death. This mechanism makes it effective against rapidly dividing cells, such as cancer cells. |
| Paclitaxel | DRUG | A chemotherapy drug that works by slowing or stopping cancer cell growth. |
| Radiation Therapy | RADIATION | Megavoltage energy photon beam irradiation. Any treatment planning and delivery system that has been credentialed for head and neck intensity-modulated radiotherapy (IMRT). Simultaneous integrated boost and sequential boost techniques (discretion of treating physician). Total doses delivered to each Planning Target Volume (PTV) (in 33-35 fractions): High: 70 Gy, Boost (if applicable): 66 Gy, Intermediate: 60-63 Gy, Elective: 56-57 Gy A sequential boost will consist of treatment of the combined PTVs 25 fractions followed by three sequential cone-downs targeting (Intermediate + Boost + High); (Boost + High); and High. Total doses for the PTVs: High: 70 Gy, Boost (if applicable): 66 Gy, Intermediate: 60 Gy, Elective: 50 Gy. |
Inclusion Criteria: 1. Pathologically confirmed and previously untreated squamous cell carcinoma of the larynx or hypopharynx 2. AJCC 8th Edition Stage III - IV disease (T1-T2/N1-N3, T3-T4/N0-N3) 3. Disease (primary \& nodal) must be potentially surgically resectable and curable with conventional s...